SILVER SPRING, Md. — The Food and Drug Administration upgraded transvaginal mesh devices to high risk Class III status, in light of the “significant risks associated with surgical mesh for repair of pelvic organ prolapse.”
Dr. William Maisel, chief scientist and deputy director at the FDA’s Center for Devices and Radiological Health, added that further adverse government action may be forthcoming. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures,” he warned. In 2011, an advisory panel told the government watchdog that these devices were unsafe and that more data was needed. In response, the FDA pursued a course of action to warn patients and limit the use of transvaginal meshes. The January 2016 announcement is the most recent component of this ongoing campaign.
In the past several years, the FDA has fielded thousands of complaints regarding severe pelvic pain, especially during intercourse, organ perforation, and serious urinary issues following implantation of this device.
Pelvic organ prolapse (POP) is a fairly common condition. The muscles around a woman’s pelvis weaken, causing the organ to slip out of place. This condition causes rather intense pain, problems urinating, and some other adverse effects. Pelvic mesh, like any other surgical mesh, is designed to keep the organ in place to alleviate these symptoms.
The FDA first notified consumers of problems in 2008. The supposedly long-lasting mesh, like the ones manufactured by Bard Medical, Johnson & Johnson, Boston Scientific, and others, quickly deteriorated, leading to even more intense pain and the possibility of multiple corrective surgeries.
Transvaginal mesh is especially dangerous because POP is not a fatal condition, and so the “cure” is literally much worse than the disease itself.
Damages in a defective medical device case include significant compensation for economic and non-economic losses, due to the serious nature of the injuries. Large punitive damage awards are also possible in these cases.
Our Transvaginal Mesh Attorneys Can Help
Our dangerous medical device lawyers help if you or someone you care about was harmed while undergoing this procedure. Lawsuits have been filed against the manufacturer by both patients and their families seeking compensation for injuries caused by the dangerous device. You may be entitled to a cash settlement.
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